Patient interface device with a frame assembly having a double-Y supporting structure

ABSTRACT

A patient interface device ( 2,102 ) is includes a cushion ( 6,106 ) and a frame assembly ( 60,160 ) coupled to the cushion, the frame assembly including a main frame member ( 4,104 ) and a stiffening structure ( 62,162 ) coupled to the main frame member, the stiffening structure having a main arm ( 64,164 ), a first Y-portion coupled to a first end of the main arm having first and second front branches extending at upward and downward angles, respectively, from the first end of the main arm, and a second Y-portion coupled to a second end of the main arm having first and second rear branches extending at upward and downward angles, respectively, from the second end of the main arm.

CROSS-REFERENCE TO RELATED APPLICATIONS

This patent application claims the priority benefit under 353 U.S.C.§371 of international patent application no. PCT/IB2011/053708, filedAug. 24, 2011, which claims the priority benefit under 35 U.S.C. §119(e)of U.S. Provisional Application No. 61/378,103 filed on Aug. 30, 2010,the contents of which are herein incorporated by reference.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to patient interface devices fortransporting a gas to and/or from an airway of a user, and inparticular, to a patient interface device having a frame assembly thatincludes a supporting structure having a double-Y configuration.

2. Description of the Related Art

There are numerous situations where it is necessary or desirable todeliver a flow of breathing gas non-invasively to the airway of apatient, i.e., without intubating the patient or surgically inserting atracheal tube in their esophagus. For example, it is known to ventilatea patient using a technique known as non-invasive ventilation. It isalso known to deliver continuous positive airway pressure (CPAP) orvariable airway pressure, which varies with the patient's respiratorycycle, to treat a medical disorder, such as sleep apnea syndrome, inparticular, obstructive sleep apnea (OSA), or congestive heart failure.

Non-invasive ventilation and pressure support therapies involve theplacement of a patient interface device including a mask component onthe face of a patient. The mask component may be, without limitation, anasal mask that covers the patient's nose, a nasal cushion having nasalprongs that are received within the patient's nares, a nasal/oral maskthat covers the nose and mouth, or a full face mask that covers thepatient's face. The patient interface device interfaces the ventilatoror pressure support device with the airway of the patient, so that aflow of breathing gas can be delivered from the pressure/flow generatingdevice to the airway of the patient. It is known to maintain suchdevices on the face of a wearer by a headgear having one or more strapsadapted to fit over/around the patient's head.

Patients that that require pressure support therapy are often confrontedwith the problem of finding a suitable patient interface device. Infinding a suitable patient interface device, such patients frequentlystruggle with issues relating to the seal and stability of the patientinterface device, the comfort of the patient interface device, thesize/weight of the patient interface device, and the sizing of thepatient interface device. These challenges, if not addressed properly,can compromise the patient's compliance with the prescribed therapy.

More specifically, during the night, the stability of a mask seal willbe challenged by the patient moving about in his or her bed. Thechanging head position can lead to air delivery hose torque and generalinterference with other objects (e.g. pillows, sheets, blankets, etc.).Thus, stability, and consequently seal, is a challenge for any patientinterface device in the market.

In addition, patient comfort is an important factor, and can benegatively impacted in many ways. For example, over-tightening of theheadgear (to compensate for lack of seal and stability) can increasepressure on the face and head, which in turn can result in pressurepoints and/or skin breakdown. Other components of the patient interfacedevice (e.g. straps, frames, headgear, etc.) can also add discomfort forthe patient because the geometry of such components can conflict withfacial structures.

Furthermore, the general weight of the patient interface device cannegatively impact a patient's experience by causing additional facialpressure or compounding over-tightening issues. Patient interface deviceweight can also negatively affect the seal and stability. Certainpatients also have problems with a patient interface device interferingwith his or her line of sight, and overall patient interface device sizehas been known to cause claustrophobia is some patients.

Finally, properly sizing a patient interface device can be difficultbecause facial structures vary greatly among patients. Not all patientinterface devices are able to accommodate this range of differences,thus requiring either more sizes/variations or not providing an optimalfit for the majority of the user population.

SUMMARY OF THE INVENTION

Accordingly, it is an object of the present invention to provide apatient interface device that overcomes the shortcomings of conventionalpatient interface device. This object is achieved according to oneembodiment of the present invention by providing a patient interfacedevice that includes a cushion and a frame assembly coupled to thecushion, the frame assembly including a main frame member and astiffening structure coupled to the main frame member, the stiffeningstructure having a main arm, a first Y-portion coupled to a first end ofthe main arm having first and second front branches extending at upwardand downward angles, respectively, from the first end of the main arm,and a second Y-portion coupled to a second end of the main arm havingfirst and second rear branches extending at upward and downward angles,respectively, from the second end of the main arm.

In another embodiment, a frame assembly for a patient interface deviceis provided that includes a main frame member and a stiffening structurecoupled to the main frame member, the stiffening structure having a mainarm, a first Y-portion coupled to a first end of the main arm havingfirst and second front branches extending at upward and downward angles,respectively, from the first end of the main arm, and a second Y-portioncoupled to a second end of the main arm having first and second rearbranches extending at upward and downward angles, respectively, from thesecond end of the main arm.

These and other objects, features, and characteristics of the presentinvention, as well as the methods of operation and functions of therelated elements of structure and the combination of parts and economiesof manufacture, will become more apparent upon consideration of thefollowing description and the appended claims with reference to theaccompanying drawings, all of which form a part of this specification,wherein like reference numerals designate corresponding parts in thevarious figures. It is to be expressly understood, however, that thedrawings are for the purpose of illustration and description only andare not intended as a definition of the limits of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a front perspective view of a patient interface deviceaccording to an exemplary embodiment of the present invention;

FIGS. 2, 3, 4 and 5 are front, rear, top and side elevational views,respectively, of a frame member of the patient interface device of FIG.1;

FIGS. 6, 7 and 8 are front perspective, front elevational and rearelevational views, respectively, of the cushion of the patient interfacedevice of FIG. 1;

FIG. 9 is a side view and FIG. 10 is an perspective view showing thepatient interface device of FIG. 1 attached to a patient;

FIGS. 11 and 12 perspective and side schematic diagrams of a frameassembly according to an alternative exemplary embodiment of theinvention;

FIG. 13 is a side elevational view of an internal support structure ofthe frame assembly shown in FIGS. 11 and 12;

FIG. 14A is a side elevational view of the stiffening structure of theframe assembly of FIGS. 11-12 having lines which indicate certaincross-sectional views thereof shown in FIGS. 14B-14G;

FIG. 15A is a side elevational view of the stiffening structure of theframe assembly of FIGS. 11-12 having lines which indicate certaincross-sectional views thereof shown in FIGS. 15B-15D;

FIG. 16A is a side elevational view of the stiffening structure of theframe assembly of FIGS. 11-12, and FIG. 16B is a cross sectional view ofthe stiffening structure of the frame assembly of FIGS. 11-12 takenalong lines Z-Z of FIG. 16A;

FIG. 17 is a front perspective view of a patient interface deviceaccording to a further embodiment of the present invention;

FIGS. 18 and 19 are front and side view, respectively, of a frame memberof the patient interface device of FIG. 17.

DETAILED DESCRIPTION OF THE EXEMPLARY EMBODIMENTS

As used herein, the singular form of “a”, “an”, and “the” include pluralreferences unless the context clearly dictates otherwise. As usedherein, the statement that two or more parts or components are “coupled”shall mean that the parts are joined or operate together either directlyor indirectly, i.e., through one or more intermediate parts orcomponents, so long as a link occurs. As used herein, “directly coupled”means that two elements are directly in contact with each other. As usedherein, “fixedly coupled” or “fixed” means that two components arecoupled so as to move as one while maintaining a constant orientationrelative to each other.

As used herein, the word “unitary” means a component is created as asingle piece or unit. That is, a component that includes pieces that arecreated separately and then coupled together as a unit is not a“unitary” component or body. As employed herein, the statement that twoor more parts or components “engage” one another shall mean that theparts exert a force against one another either directly or through oneor more intermediate parts or components. As employed herein, the term“number” shall mean one or an integer greater than one (i.e., aplurality).

Directional phrases used herein, such as, for example and withoutlimitation, top, bottom, left, right, upper, lower, front, back, andderivatives thereof, relate to the orientation of the elements shown inthe drawings and are not limiting upon the claims unless expresslyrecited therein.

FIG. 1 is a front perspective view of a patient interface device 2according to an exemplary embodiment of the present invention. FIG. 9 isa side view and FIG. 10 is a front perspective view showing patientinterface device 2 attached to a patient. Patient interface device 2includes a frame member 4 and a cushion 6 coupled to frame member 4,each of which is described in greater detail herein.

FIGS. 2, 3, 4, and 5 are front, rear, top and side elevational views,respectively, of frame member 4 of patient interface device 2. Framemember 4 includes a generally annular central member 8 having first andsecond main arms 10A, 10B extending outwardly from opposites sidesthereof. Main arm 10A includes orifice 12A extending therethrough, andmain arm 10B includes orifice 12B extending therethrough. In theexemplary embodiment, orifices 12A, 12B are positioned at a location onmain arms 10A, 10B adjacent central member 8. The purpose of orifices12A, 12B is described in detail elsewhere herein. In addition, as seenin FIGS. 2 and 3, central member 8 defines central orifice 14.

Frame member 4 further includes a first branching member 16A extendingupwardly at an angle from main arm 10A and a first branching member 16Bextending upwardly at an angle from main arm 10B. In one particular,non-limiting embodiment, first branching members 16A, 16B extendupwardly from the respective main arm 10A, 10B at an angle of about 60degrees, although other angles are also possible. Furthermore, framemember 4 also includes a second branching member 18A extendingdownwardly at an angle from main arm 10A and a second branching member18B extending downwardly at an angle from main arm 10B. In oneparticular, non-limiting embodiment, second branching members 18A, 18Bextend downwardly from the respective main arm 10A, 10B at an angle ofabout 30 degrees], although other angles are also possible. Also in oneparticular, non-limiting embodiment, main arms 10A and 10B extend forabout 55-60 mm from the center of orifices 12A, 12B to the inner anglesformed between the branching members 16A and 18A and 16B and 18B,respectively.

Moreover, as seen in FIGS. 1-5, the distal end of each of firstbranching member 16A, 16B and second branching member 18A, 18B includesa respective loop member 20 for receiving a respective strap 22 ofheadgear assembly 24 (FIGS. 9 and 10). In the exemplary embodiment,frame member 4 is made of a thermoplastic or thermoset material.

FIGS. 6, 7, and 8 are front perspective, front elevational and rearelevational views, respectively, of cushion 6 of patient interfacedevice 2. In the exemplary embodiment, cushion 6 is defined from aunitary piece of soft, flexible, cushiony, elastomeric material, suchas, without limitation, silicone, an appropriately soft thermoplasticelastomer, a closed cell foam, or any combination of such materials.Cushion 6 includes a main body portion 40 having a sealing portion 42coupled to a first end thereof. Sealing portion 42 is structured to forma seal against a face of the patient. In the illustrated embodiment,cushion 6 is in the form of a nasal mask. However, other types ofpatient sealing assemblies, such as a nasal/oral mask, nasal cannula, ora nasal cushion, which facilitate the delivery of the flow of breathinggas to the airway of a patient, may be substituted for cushion 6 whileremaining within the scope of the present invention.

In addition, main body portion 40 defines orifice 44 at the second endthereof opposite the first end. Orifice 44 is structured to enablecushion 6 to be fluidly coupled to a fluid connector such as an elbowconduit, which in turn is fluidly coupled a pressure generating devicesuch as a ventilator or a CPAP machine through a gas delivery hose.

Cushion 6 further includes generally cylindrically shaped posts 46A and46B extending from first and second sides 48A and 48B, respectively, ofmain body 40. Each post 46A, 46B is positioned about midway between thefirst and send end of cushion 6. In addition, each post 46A, 46Bincludes inner cylindrical portion 50, enlarged portion 52, and outercylindrical portion 54.

When patient interface device 2 is assembled, the second end of mainbody 40 is inserted through central orifice 14 defined by central member8. In addition, post 46A is inserted through orifice 12A and post 46B isinserted through orifice 12B. More specifically, as seen in FIG. 1, ineach case, outer cylindrical portion 54 and enlarged portion 52 areinserted through the respective orifice 12A, 12B such that each enlargedportion 52 rests against the outer surface of main arm 10A, 10B andprevents outer cylindrical portion 54 from sliding back through orifice12A, 12B. In addition, each inner cylindrical portion 50 is able to turnwithin the respective orifice 12A, 12B.

The branching nature of the sides of frame member 4, giving it a “T” or“Y” shape, allows for flexing of frame member 4 in certain directionswhile at the same time limiting flexing in other directions. Inparticular, main arms 10A, 10B are able to flex in the directions shownby the arrows in FIG. 4 (i.e., parallel to the top and bottom surface ofmain arms 10A, 10B), but are not able to freely flex in a directiontransverse to the longitudinal axis thereof (i.e., perpendicular to thetop and bottom surface of main arms 10A, 10B). In addition, each of thefirst branching members 16A, 16B and second branching member 18A, 18Bare able to flex independently of one another in the directions shown bythe arrows in FIG. 4 (i.e., parallel to the top and bottom surface ofthe branching members), but are not able to freely flex in a directiontransverse to the longitudinal axis thereof (i.e., perpendicular to thetop and bottom surface of the branching members). This controlledflexing addresses several issues present in the prior art relating toseal, stability and comfort discussed elsewhere herein, as it passivelyaccommodates for many facial and head geometries to allow for optimalfit and comfort. The branched structure of frame member 4 also increasesthe stability of patient interface device 2 through patient movement andhose torque, which provides an optimal seal for the patient.

In addition, the selection of the material for frame member 4 inconjunction with the geometry of frame member 4 as described hereinallows for flexing to accommodate the vast variation in patient facialstructures and head dimensions. In the exemplary embodiment, thematerial will be soft enough to provide for flexing in the desireddirections as described herein, but rigid enough to limit the flexing innon-desired directions as described herein. Also, the geometry will, inthe exemplary embodiment, allow for accommodation of not only thetemple, cheek and jaw regions, but will also cover varying head sizesand nose locations. The geometry of portions of frame member 4 may, forexample, vary in thickness, existence of ribs or other structures,and/or general dimensioning to accommodate differences in flexing due tothe material properties, but will maintain the branching shape describedherein.

Other alternative methods of controlling the direction of flexing offrame ember 4 in the various directions can be accomplished with the useof structures such as hinges incorporated therein. The hinge can beaccomplished in a number of different ways, such as with mechanicalinterlocking (removable or permanent) or overmolding with materials suchas silicone or other elastomers.

Furthermore, the branching nature of the sides of frame member 4, givingit the “T” or “Y” shape discussed above, moves the mounting or anchorpoint (i.e., loops 20) for patient interface device 2 on the head of thepatient through headgear assembly 24 further back along the side of thehead. Typical mounting locations of nasal masks have been on one or manyof the following: cheeks, forehead, and chin By moving the mountingpoint away from the front of the face, it improves the issues withclaustrophobia and line of sight infringement. It also limits thepressure and potential discomfort from over-tightening to the lesssensitive areas of the face.

In addition, the interaction between posts 46A, 46B and orifices 12A,12B provide the connection point for cushion 6 to frame 4. Thatconnection point provides for a passive auto-adjustment mechanism forcushion 6, as posts 46A and 46B, and thus cushion 6, are able to rotaterelative to frame member 4. In the exemplary embodiment, each post 46A,46B has enough interference with frame member 4 to limit excessiverotation but not enough resistance to prevent auto-adjustment. Also inthe exemplary embodiment, the cylindrical shape of each post 46A, 46B,as opposed to an oval or other geometry, allows for an infinite amountof positions instead of discrete positioning. This auto-adjustingfeature optimizes the angle of engagement of cushion 6 to the face ofthe patient and increases the chance for an optimal seal across manypatient faces of differing sizes and shapes. It also decreases thechance of undue pressure along the sealing portion 42 of cushion 6 onthe face (particularly the upper lip) of the patient. Lastly, thisauto-adjusting feature provides the ability of cushion 6 to adjustduring patient movement, thus increasing stability throughout the night.

Thus, the combination of the flexing frame member 4 and theauto-adjusting cushion 6 allows for placement of frame member 4 on theface to vary in order to meet the individual patient's needs. Thisallows an opportunity for the patient to alleviate any possible pressurepoints and/or optimize seal and stability. In addition, the mountingpoint of cushion 6 to frame member 4 has been moved closer to thepatient's face, which increases the stability of patient interfacedevice 2 by moving the fulcrum closer to the patient's face (moment armdecreases). It also lessens the overall profile of patient interfacedevice 2, creating a lower profile that improves overall size andappearance.

An alternative exemplary embodiment of the invention is shown in FIGS.11 and 12, and includes frame assembly 60 which may be coupled tocushion 6 as described elsewhere herein or another suitable cushion,such as, without limitation, a known or hereafter developed nasal/oralmask, nasal cushion, pillows style cushion or full face mask. Frameassembly 60 includes a frame member 4 as described elsewhere hereinhaving inserts provided therein or attached (e.g., bonded) thereto(i.e., to the exterior surface) in the form of right and left stiffeningstructures 62A and 62B. In the exemplary, non-limiting embodiment, framemember 4 is made of a high durometer silicone, such as, withoutlimitation, 75 Shore A (±5 Shore A) durometer LSR (liquid siliconerubber), overmolded onto right and left stiffening structures 62A and62B as shown in FIGS. 11 and 12. Also in the exemplary embodiment,stiffening structures 62A and 62B are made of a thermoplastic materialsuch as a polycarbonate like HP4, although other materials, such aspolypropylene, may also be used. In addition, frame assembly 60 couldhave a fabric covering or other surface treatment or texturing foraesthetics, patient comfort, or for the wicking of moisture orpatient-caused heat.

FIG. 13 is a side elevational view of left stiffening structure 62B.Right stiffening structure 62A is identical in structure and symmetricalto left stiffening structure 62B. Stiffening structures 62A and 62B eachhave a generally double-Y shaped footprint, wherein one of the Yportions faces the patient's ear while the other of the Y portions facesthe cushion attached to frame assembly 60 (which, as discussed elsewhereherein, could be a nasal cushion, a nasal/oral mask, a pillows cushionor a full face cushion). In particular, stiffening structures 62A and62B each include main arm 64 having orifice 66, front branches 68 and 70extending at upward and downward angles, respectively, from main arm 64,and rear branches 72 and 74 extending at upward and downward angles,respectively, from main arm 64.

In the exemplary embodiment, main body 64, front branches 68 and 70, andrear branches 72 and 74 each have a thickness of about 0.058 inches anda width of about 0.25 inches. Also in the exemplary embodiment, mainarms 10A, 10B and branching members 16A, 16B, 18A, 18B have a thicknessof about 0.125 inches and a width of about 0.475 inches. The purpose ofstiffening structures 62A and 62B is to provide vertical support andstabilize cushion 6 and preserve the patient seal while forces areexerted thereon as a result of patient movement (e.g., hose relatedforces). The mask-side-Y (front branches 68 and 70) has a generallysymmetric shape with respect to line AA shown in FIGS. 12 and 13, whilethe ear-side-Y (rear branches 72 and 74) is asymmetric with respect toline AA shown in FIGS. 12 and 13.

In one particular embodiment, the portion of each stiffening structure62A, 62B between each Y has a length (labelled as l₁ in FIG. 12) of55-60 mm. This size is key in positioning the ear-side-Y such that theheadgear connections and force vectors are away from the immediateregion of the cushion and yet negotiate around the ear region for themajority of the patient population. The ear-side-Y has an upper member(rear branch 72) that has a centerline that positioned at an angle αwith respect to the line AA of FIG. 12 (the centerline of main arm 64).In the illustrated embodiment, α is roughly 60 degrees. Theear-side-lower member (rear branch 74) has a centerline that positionedat an angle θ with respect to the line AA of FIG. 12. In the illustratedembodiment, θ is roughly 30 degrees. In addition, in the illustratedembodiment, the upper member of the ear-side-Y (rear branch 72) extendsalong half of associated first branching member 16A, 16B such that d₁=d₂as shown in FIG. 12. The lower member of the ear-side-Y (rear branch 72)extends roughly the length of the associated first branching member 18A,18B (up to a point adjacent to where loop member 20 begins).

FIG. 14A is a side elevational view of stiffening structure 62B havinglines which indicate certain cross-sectional views of stiffeningstructure 62B shown in FIGS. 14B-14G. Referring to FIGS. 14A-14G, in theexemplary embodiment, the degree of cross-sectional curvature (withreference to the longitudinal axis of main arm 64) of the ear-side-Y(i.e., of both rear branch 72 and rear breach 74) decreases from thefirst end of the ear-side-Y immediately adjacent to the end of main arm64 to the distal end of the ear-side-Y (i.e., the distal end of bothrear branch 72 and rear breach 74). In particular, as shown in FIGS.14B-14G, that decreasing curvature is prescribed by the ear-side-Yhaving a succession of cross-sectional radii R₁ through R₆ that increasefrom the first end of the ear-side-Y to the distal end of the ear-side-Y(R₁<R₂<R₃<R₄<R₅<R₆). This curvature is designed to match the contours ofthe human face for the majority of the patient population. In oneparticular embodiment, R₁=116.85 mm, R₂=132.59 mm, R₃=159.51 mm,R₄=223.23 mm, R₅=247.66 mm, and R₆=421.98 mm.

FIG. 15A is a side elevational view of stiffening structure 62B havinglines which indicate certain cross-sectional views of stiffeningstructure 62B shown in FIGS. 15B-15D. Referring to FIGS. 15A-15D, in theexemplary embodiment, the degree of cross-sectional curvature (withreference to the longitudinal axis of main arm 64) of the mask-side-Y(i.e., of both front branches 68 and 70) increases from the first end ofthe mask-side-Y immediately adjacent to the end of main arm 64 to thedistal end of the mask-side-Y (i.e., the distal end of both front branch68 and front breach 70). In particular, as shown in FIGS. 15B-15D, thatincreasing curvature is prescribed by the mask-side-Y having asuccession of cross-sectional radii R₇ through R₉ that decrease from thefirst end of the ear-side-Y to the distal end of the ear-side-Y(R₇>R₈>R₉). In one particular embodiment, R₇=32.59 mm, R₈=32.31 mm, andR₃=30.44 mm.

FIG. 16A is a side elevational view of stiffening structure 62A, andFIG. 16B is a cross sectional view of stiffening structure 62A takenalong lines Z-Z of FIG. 16A. As seen in FIG. 16B, main arm 64 has acurvature that is prescribed by radii R₁₀, R₁₁ and R₁₂. In oneparticular embodiment, R₁₀=181.07 mm, R₁₁=1520.95 mm, and R₁₂=121.46 mm.

FIG. 17 is a front perspective view of a patient interface device 102according to a further embodiment of the present invention, and FIGS. 18and 19, are front and side view, respectively, of a frame member 104 ofthe patient interface device of FIG. 17. Patient interface device 102 isgenerally similar to patient interface device 2 describe above with someof the differences being discussed in detail below. As in the previousembodiment, a cushion 106 is attached to a frame assembly 160 thatincludes a frame member 104 such that the cushion is moveable relativeto the frame member.

Frame member 104 includes a generally annular central member 103 havingfirst and second main arms 110A and 110B. An opening 99 is defined incentral member 103. Frame member 104 includes a first branching member116A extending upwardly at an angle from main arm 110A and a firstbranching member 116B extending upwardly at an angle from main arm 110B.In one particular, non-limiting embodiment, first branching members116A, 116B extend upwardly from the respective main arm 110A, 110B at anangle of about 63 degrees±5 degrees, although other angles are alsopossible. Note that branching members 116A, 116B are more curved or havea more arcuate shape than the branching members of the previousembodiments. This curbed shape is believed to provide a frame that moreclose conforms to the anatomy of a human head.

Furthermore, frame member 104 also includes a second branching member118A extending downwardly at an angle from main arm 110A and a secondbranching member 118B extending downwardly at an angle from main arm110B. In one particular, non-limiting embodiment, second branchingmembers 118A, 118B extend downwardly from the respective main arm 110A,110B at an angle of about 44 degrees±5 degrees, although other anglesare also possible. Note that branching members 118A, 118B are morecurved or have a more arcuate shape than the branching members of theprevious embodiments. This curbed shape is believed to provide a framethat more close conforms to the anatomy of a human head. The distal endof each of first branching member 116A, 116B and second branching member118A, 118B includes a respective loop member 120 for receiving arespective strap of headgear assembly 24.

In this embodiment, the coupling of cushion 106 to the frame member isaccomplished via a coupling assembly 107 that includes a pair ofprotrusions 109 provided on each side of a collar 105 coupled to cushion106. In the illustrated embodiment, at least a portion of eachprotrusion 109 is seated or disposed in a slot or groove 108 that isprovided in frame member 104. This arrangement allows cushion 106 tomove relative to frame member 104 by, for example, pivoting about anaxis defined through protrusions 109. Such movement allows the cushionto automatically seat itself on the patient when the patient interfacedevice is donned by the user.

In the exemplary embodiment, each main arm 110A and 110B of frame member104 is defined by a stiffening member 162 disposed in a flexiblematerial. In an exemplary embodiment, the stiffening member is definedby a plastic and the flexible material is a compressed foam covered infabric. Stiffening structures 162 each include a main arm 164, frontbranches 168 and 170 extending at upward and downward angles,respectively, from main arm 164, and rear branches 172 and 174 extendingat upward and downward angles, respectively, from main arm 164. In theexemplary embodiment, angle of α=63+5 degrees and angle θ=44+5 degrees.Front branches 168 and 170 and rear branches 172 and 174 are generallylonger than in previous embodiments and are also less wide.

Although the invention has been described in detail for the purpose ofillustration based on what is currently considered to be the mostpractical and preferred embodiments, it is to be understood that suchdetail is solely for that purpose and that the invention is not limitedto the disclosed embodiments, but, on the contrary, is intended to covermodifications and equivalent arrangements that are within the spirit andscope of the appended claims. For example, it is to be understood thatthe present invention contemplates that, to the extent possible, one ormore features of any embodiment can be combined with one or morefeatures of any other embodiment.

What is claimed is:
 1. A patient interface device, comprising: acushion; and a frame assembly coupled to the cushion, the frameassembly, comprising: a main frame member having a first arm, a secondarm, and a generally annular central member defining a central orifice,wherein the first arm extends from a first side of the central memberand the second arm extends from a second side of the central member, anda first stiffening structure and a second stiffening structure, thefirst and second stiffening structures each being an insert made of aplastic material and being disposed entirely inside the main framemember, the first and second stiffening structures each having a mainarm, a first Y-portion coupled to a first end of the main arm havingfirst and second front branches extending at upward and downward angles,respectively, from the first end of the main arm, and a second Y-portioncoupled to a second end of the main arm having first and second rearbranches extending at upward and downward angles, respectively, from thesecond end of the main arm, wherein the first and second front branchesof the first Y-portion of the first stiffening structure are disposedwithin a first side portion of the central member and the first andsecond front branches of the first Y-portion of the second stiffeningstructure are disposed within a second side portion of the centralmember opposite the first side portion of the central member in a mannersuch that respective ends of the first front branches of the firstY-portion of the first stiffening structure and the first Y-portion ofthe second stiffening structure are spaced from one another within thecentral member and respective ends of the second front branches of thefirst Y-portion of the first stiffening structure and the secondY-portion of the second stiffening structure are spaced from one anotherwithin the central member.
 2. The patient interface device according toclaim 1, wherein the cushion includes a main body having a first end anda second end opposite the first end, the first end including a fluidcoupling orifice and the second end including a patient sealing portion,and wherein the first end of the cushion is received through the centralorifice such that the first end of the cushion is positioned on a firstside of the central member and the second end of the cushion ispositioned on a second side of the central member opposite the firstside of the central member.
 3. The patient interface device according toclaim 1, wherein respective ends of the first front branches of thefirst Y-portion of the first stiffening structure and the firstY-portion of the second stiffening structure are spaced from one anotherwithin the central member thereby defining a first space within thecentral member and the respective ends of the front branches respectiveends of the second front branches of the first Y-portion of the firststiffening structure and the second Y-portion of the second stiffeningstructure are spaced from one another within the central member therebydefining a second space within the central member wherein the firstspace is located at a top of the central member and the second space islocated at a bottom of the central member opposite the top of thecentral member.
 4. The patient interface device according to claim 1,further comprising a headgear component having a first strap portion, asecond strap portion, a third strap portion, and a fourth strap portion,wherein the first arm of the main frame member includes a firstbranching member extending upwardly from a first end of the first armand including a first attachment member and a second branching memberextending downwardly from the first end of the first arm and including asecond attachment member, wherein the second arm of the main framemember includes a third branching member extending upwardly from a firstend of the second arm and including a third attachment member and afourth branching member extending downwardly from the first end of thesecond arm and including a fourth attachment member, and wherein thefirst strap portion is coupled to the first attachment member, thesecond strap portion is coupled to the second attachment member, thethird strap portion is coupled to their attachment member, and thefourth strap portion is coupled to the fourth attachment member.
 5. Aframe assembly for a patient interface device, comprising: a main framemember having a first arm, a second arm, and a generally annular centralmember defining a central orifice, wherein the first arm extends from afirst side of the central member and the second arm extends from asecond side of the central member; and a first stiffening structure anda second stiffening structure, the first and second stiffeningstructures each being an insert made of a plastic material and beingdisposed entirely inside the main frame member, the first and secondstiffening structures each having a main arm, a first Y-portion coupledto a first end of the main arm having first and second front branchesextending at upward and downward angles, respectively, from the firstend of the main arm, and a second Y-portion coupled to a second end ofthe main arm having first and second rear branches extending at upwardand downward angles, respectively, from the second end of the main arm,wherein the first and second front branches of the first Y-portion ofthe first stiffening structure are disposed within a first side portionof the central member and the first and second front branches of thefirst Y-portion of the second stiffening structure are disposed within asecond side portion of the central member opposite the first sideportion of the central member in a manner such that respective ends ofthe first front branches of the first Y-portion of the first stiffeningstructure and the first Y-portion of the second stiffening structure arespaced from one another within the central member and respective ends ofthe second front branches of the first Y-portion of the first stiffeningstructure and the second Y-portion of the second stiffening structureare spaced from one another within the central member.
 6. The frameassembly according to claim 5, wherein the main frame member is made ofa silicone material, and wherein the main frame member is overmoldedonto the stiffening structure.
 7. The frame assembly according to claim6, wherein the main frame member is made of a material having a Shore Adurometer of between 70 and 80 Shore A.
 8. The frame assembly accordingto claim 5, wherein each first Y-portion is symmetrical with respect toa line through the main arm thereof along a longitudinal axis of themain arm thereof, and wherein each second Y-portion is asymmetrical withrespect to the line.
 9. The frame assembly according to claim 5, whereineach main arm has a length of between 55 and 60 mm.
 10. The frameassembly according to claim 8, wherein each first rear branch has acenterline along a longitudinal axis thereof that is positioned at anangle of about 60 degrees with respect to the line.
 11. The frameassembly according to claim 10, wherein each second rear branch has acenterline along a longitudinal axis thereof that is positioned at anangle of about 30 degrees with respect to the line.
 12. The frameassembly according to claim 5, wherein the first arm of the main framemember includes a first branching member having a first length extendingupwardly from a first end of the first arm and a second branching memberextending downwardly from the first end of the first arm, wherein thefirst rear branch of the first stiffening member has a second lengththat is equal to about one half the first length.
 13. The frame assemblyaccording to claim 5, wherein a degree of cross-sectional curvature ofeach of the first rear branch and the second rear branch of the firststiffening member decreases from a first end of the second Y-portion ofthe first stiffening member immediately adjacent to the second end ofthe main arm to a distal end of each of the first rear branch and thesecond rear branch of the first stiffening member.
 14. The frameassembly according to claim 5, wherein a degree of cross-sectionalcurvature of the first Y-portion of the first stiffening memberincreases from a first end of the first Y-portion of the firststiffening member immediately adjacent to the first end of the main armto a distal end of each of the first front branch and the second frontbranch of the first stiffening member.
 15. The frame assembly accordingto claim 5, wherein the main frame member comprises a compressed foamcovered in a fabric material.
 16. The frame assembly according to claim5, wherein respective ends of the first front branches of the firstY-portion of the first stiffening structure and the first Y-portion ofthe second stiffening structure are spaced from one another within thecentral member thereby defining a first space within the central memberand the respective ends of the front branches respective ends of thesecond front branches of the first Y-portion of the first stiffeningstructure and the second Y-portion of the second stiffening structureare spaced from one another within the central member thereby defining asecond space within the central member wherein the first space islocated at a top of the central member and the second space is locatedat a bottom of the central member opposite the top of the centralmember.
 17. The frame assembly according to claim 5, wherein the firstarm of the main frame member includes a first branching member extendingupwardly from a first end of the first arm and including a firstattachment member and a second branching member extending downwardlyfrom the first end of the first arm and including a second attachmentmember, wherein the second arm of the main frame member includes a thirdbranching member extending upwardly from a first end of the second armand including a third attachment member and a fourth branching memberextending downwardly from the first end of the second arm and includinga fourth attachment member.